REPROCESSED ATHROSCOPICS BURS— 510(k) K012605

Name: FDA 510(k) clearance K012605
Creator: U.S. Food and Drug Administration
Published: 2001-11-07

Substantially Equivalent

Alliance Medical Corp.

FDA 510(k) clearance K012605 for REPROCESSED ATHROSCOPICS BURS, Substantially Equivalent on 2001-11-07. Applicant: Alliance Medical Corp.. Device class: 2.

Clearance details

Applicant: Alliance Medical Corp.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2001-08-13
Decision date: 2001-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

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K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

More clearances from Alliance Medical Corp.

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K060648 — REPROCESSED PHACOEMULSIFICATION TIPS2007-03-19
K061045 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS2006-08-31
K060049 — REPROCESSED COMPRESSION SLEEVES2006-02-24
K060091 — ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES2006-02-17
K053316 — REPROCESSED COMPRESSION SLEEVES2006-02-13

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K012605

K-number listed on FDA's recall record

Z-0973-2019 — Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.Class II·Terminated·Stryker Sustainability Solutions·20180727

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012605.

Data sourced from openFDA. This site is unofficial and independent of the FDA.